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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06193863
Other study ID # 22468
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 31, 2024
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email clinical-trials-contact@bayer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery called the Fontan procedure. Congenital heart disease (CHD) is a heart problem that some children are born with. It sometimes requires a surgery called the Fontan procedure to improve the blood flow in the body. The Fontan procedure can increase the risk of the formation of blood clots in the blood vessels (called thrombosis), which might lead to death. The study drug, rivaroxaban, is an approved treatment for preventing the formation of blood clots. It is a type of anticoagulant that prevents the blood from clotting by blocking a protein responsible for it. Rivaroxaban can increase the risk of bleeding. A previous study suggested that the number of major bleeding episodes did not differ much while taking rivaroxaban compared to aspirin in children with CHD who had undergone the Fontan procedure. However, there is limited information available for Japanese patients. To better understand the safety and potential risks of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world. The main purpose of this study is to learn more about the occurrence of major bleeding or non-major bleeding in children who were treated with rivaroxaban. Major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person's health and requires medical attention. Non-major bleeding is defined as a type of bleeding that may negatively impact a person's health if not treated. The data will be collected from December 2023 to June 2026. Researchers will observe each participant for up to 30 days after stopping the treatment or for a maximum of 2 years. In this study, only available data from regular health visits will be collected. No visits or tests are required as part of this study. Researchers will use the medical records or interview the children and/or their guardians during regular visits.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 31, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Patients under the age of 18 years - Patients diagnosed with CHD who had undergone the Fontan procedure by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with rivaroxaban by the investigator under routine clinical practice - Informed consent form obtained from a legal representative Exclusion Criteria: - Participation in an investigational program with interventions outside of routine clinical practice - Contraindications according to the local marketing authorization - Previous treatment with rivaroxaban

Study Design


Intervention

Drug:
Rivaroxaban (Xarelto, BAY59-7939)
At the discretion of the treating physician, based on the recommendations written in the local product information.

Locations

Country Name City State
Japan Many Locations Multiple Locations

Sponsors (2)

Lead Sponsor Collaborator
Bayer Janssen Research & Development, LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of major bleeding or clinically relevant non-major bleeding Up to 2 years
Secondary Occurrence of any bleeding Up to 2 years
Secondary Occurrence of all adverse events (AEs) Up to 2 years
Secondary Occurrence of thrombotic events Up to 2 years
Secondary Descriptive summary of patient demographics/characteristics Up to 2 years
Secondary Dosing patterns of rivaroxaban Up to 2 years
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